By Ryan Murray, M.Sc., and Amanda McFarland, M.Sc., ValSource, Inc.

Read our recent publication with Outsourced Pharma — “CDMOs And Contamination Control Strategy: The Span Of Oversight In EU GMP Annex 1 Compliance,” authored by ValSource team members Ryan Murray, Senior Consultant & Amanda Bishop McFarland.

By Ryan Murray, M.Sc., and Amanda McFarland, M.Sc., ValSource, Inc.

Over the last several years, various revisions of the EU’s Annex 11 have been released and reviewed by countless numbers of subject matter experts across our industry. The final version is now published, and it is time to take action. Read more from Ryan Murray, M.Sc., and Amanda McFarland, M.Sc.

By Amanda McFarland, M.Sc., Senior Consultant at ValSource, Inc.

This article presents the first four steps of an initial evaluation roadmap for modern microbial methods. These steps comprise the initial technology assessment, data and compliance risk, cost considerations and an overall instrument evaluation.

By Jim Vesper, Ph D., ValSource Inc.

As someone who has been involved in risk management for a number of years, it has been interesting during COVID-19 to step back and reflect on some of my recent decisions and actions: Do we host a holiday party for 80 people? How about a smaller event for 30 people who all claim to have been fully vaccinated? Do we go to a restaurant that requires proof of vaccination? What about that gathering with some friends we haven’t seen in nearly two years but haven’t been vaccinated?

The responses to these questions – and many others – are based on how much risk we are willing to accept or reject, or more specifically in the vocabulary of risk management, our risk appetite and risk tolerance.

This article describes and differentiates risk appetite and risk tolerance and discusses why these two concepts are foundational to how we make risk-based decisions.

By Amanda McFarland, M.Sc., Senior Consultant at ValSource, Inc.

Plot A Successful Course: Critical Risk Assessments With CDMOs – Amanda McFarland

By ValSource’s Marc Glogovsky & Paula Peacos

PDA Technical Report No. 88, written by ValSource’s Marc Glogovsky & Paula Peacos, along with other industry experts, presents a holistic approach for performing a microbiological investigation. It provides a framework to assist with focusing on the investigational areas that may contain or contribute to the root cause of data deviations, such as sampling, test methodology, and suitability of the test, as opposed to providing methods for analysis of batch acceptability.

The distinct areas where microbial data is collected and inspected for deviation investigations are the focus of this document, including:

1) Roles and responsibilities of personnel, especially microbiologists, in the laboratory investigations and cross-functional teams responsible for manufacturing investigations,

2) Conducting laboratory investigations, and

3) Conducting manufacturing investigations.

The roles of other contributors to deviation investigations required for effective root cause analysis, such as representatives from manufacturing, process engineering, and quality assurance, are also briefly described.

This technical report promotes a lifecycle approach, but greater emphasis is placed on laboratory and manufacturing investigations of marketed drug products.

Full Technical Report available for download by February 13, 2022.

Guest Column Article by Tiffany Baker, Danica Brown, and Amanda McFarland of ValSource, Inc.

Guest Column Article by Tiffany Baker, Danica Brown, and Amanda McFarland of ValSource, Inc.

By John Weisgerber, ValSource Senior Project Manager

At ValSource, we only use certified labs to calibrate our test standards, adhering to NIST traceable standards. John Weisgerber, ValSource Senior Project Manager, outlines the key advantages of using an accredited lab for equipment calibration.

This is the 4th episode in our series focused on Advanced Therapeutic Medical Products (ATMPs) that includes cell and gene therapies. Specifically, we’ll be discussing ATMP/CGT and working with third parties. Providing their knowledge are 3 ValSource colleagues who have a wealth of experience: Ryan Murray, Steven Langille, and Darius Pillsbury.